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Post Marketing Surveillance On The Safety And Tolerability Of Sunitinib Malate (Sutent) For Filipino Patients

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Metastatic Renal Cell Carcinoma

Intervention: Sunitinib malate (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

The primary purpose is to monitor the safety and tolerability and effectiveness of sunitinib malate in the treatment of patients with metastatic renal cell carcinoma and gastrointestinal stromal tumor among filipino patients in usual clinical practice setting.

Clinical Details

Official title: Post Marketing Surveillance On The Safety And Tolerability Of Sunitinib Malate (Sutent) For Filipino Patients

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Safety and tolerability of sunitinib malate as measured by the incidence, severity, seriousness and relatedness to treatment adverse events (AEs), laboratory abnormalities, vital signs (blood pressure) and the use of concomitant medications.

Secondary outcome: Effectiveness of sunitinib malate will be measured by the overall response as determined by the objective tumor assessments made according to the Response Evaluation Criteria in Solid Tumors (RECIST).

Detailed description: Open label

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Age 18 years and above

- Diagnosed with metastatic renal cell carcinoma or gastrointestinal stromal tumor

after imatinib treatment failure or intolerance Exclusion Criteria:

- Subjects with conditions that are contraindicated with sunitinib malate

Locations and Contacts

Chong Hua Hospital, Cebu City, Philippines

Private Clinic, Manila, Philippines

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: February 2010
Last updated: July 3, 2013

Page last updated: August 23, 2015

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